Gilead CEO Daniel O'Day attends a meeting with the President and other biopharma leaders at the White House on March 2, 2020 (AP Photo)

Ramp­ing up glob­al pro­duc­tion of remde­sivir, Gilead CEO Dan O’Day de­tails plans to dis­trib­ute 1.5M dos­es to fight Covid-19 — for free

Gilead is still some days away from turn­ing the card on its first round of da­ta on remde­sivir’s abil­i­ty to fight se­vere cas­es of Covid-19, but the big biotech is ramp­ing up an emer­gency sup­ply of a mil­lion cours­es of ther­a­py as it starts free dis­tri­b­u­tion of the drug to tens of thou­sands of pa­tients un­der their com­pas­sion­ate use and ex­pand­ed ac­cess pro­gram as well as clin­i­cal tri­als.

In his lat­est open let­ter post­ed over the week­end, Gilead CEO Dan O’Day out­lined how the com­pa­ny has been suc­cess­ful in cut­ting pro­duc­tion time on remde­sivir while re­pur­pos­ing some of their own fa­cil­i­ties and turn­ing to con­tract man­u­fac­tur­ers to build a near-term sup­ply of 1.5 mil­lion dos­es. They are still work­ing on ef­fi­ca­cy and dos­ing, but that sup­ply could cov­er 140,000 cours­es of treat­ment. That sup­ply, he added, would be more wide­ly avail­able fol­low­ing a po­ten­tial ap­proval.

They’re al­so not done. O’Day says that the com­pa­ny is build­ing a glob­al sup­ply chain of raw ma­te­ri­als and its pro­duc­tion ca­pac­i­ty — em­pha­siz­ing the need for a glob­al re­sponse to the pan­dem­ic that has spread like wild­fire around the plan­et.

By this Oc­to­ber, O’Day ex­pects to have a half mil­lion cours­es ready, boost­ing that to a mil­lion by the end of the year.

He writes:

Our ef­forts to in­crease sup­ply con­tin­ue with a strong sense of ur­gency. There is a long way to go and a lot of work to be done but I’m pleased that, de­spite the chal­lenges we have been able to get sup­ply lev­els to where they are to­day in a very short space of time – through the re­source­ful­ness of our teams, cre­ative ap­proach­es and col­lab­o­ra­tion.

O’Day re­cent­ly con­firmed the com­pa­ny’s de­vel­op­ment time­line, not­ing that the first da­ta is ex­pect­ed this month. It will be one of the most close­ly-watched da­ta read­outs of the decade.

Ge­of­frey Porges at SVB Leerink be­lieves Gilead could play a ma­jor role in ad­dress­ing the coro­n­avirus pan­dem­ic that has turned the world up­side down in in the last month or 2.

Should remde­sivir pro­duce a 20-30% re­duc­tion in the mor­tal­i­ty from COVID19, or im­prove oth­er mark­ers of clin­i­cal pro­gres­sion such as ven­ti­la­tor days or resid­ual mor­bid­i­ty, then the com­mu­ni­ty at large (world­wide) is like­ly to breath a huge sigh of re­lief at the prospect of mak­ing this dis­ease more man­age­able med­ical­ly and eco­nom­i­cal­ly. The news from the first tri­als of remde­sivir is like­ly to be dis­closed this week, and could be a ma­jor cat­a­lyst for a change in sen­ti­ment in eq­ui­ty mar­kets should the drug be ef­fec­tive.

Gilead has be­come some­thing of a light­ning rod dur­ing the pan­dem­ic, with one of the most ad­vanced ther­a­pies in the clin­ic. Its move to gain an or­phan drug des­ig­na­tion for remde­sivir was roast­ed by con­sumer ad­vo­cates, who saw it as an at­tempt to un­fair­ly prof­it off the cri­sis. And O’Day quick­ly backed away, drop­ping the mar­ket in­cen­tives that the FDA of­fers for rare dis­ease drugs.

Gilead has re­peat­ed­ly been sin­gled out over the years for its pric­ing prac­tices, draw­ing the ire of AIDS ad­vo­cates and more re­cent­ly as­tound­ing pay­ers with their ini­tial stick­er price on a pain­less cure for hep C that quick­ly earned a for­tune — and just as quick­ly melt­ed away as the drug worked as billed.

In set­ting course for ini­tial­ly dis­trib­ut­ing large amounts of the drug for free, Gilead now has a chance to re­form its im­age while help­ing set the course for oth­ers to fol­low.

Gilead re­cent­ly backed away from pro­vid­ing the drug for in­di­vid­ual com­pas­sion­ate use re­quests af­ter get­ting in­un­dat­ed with pleas. And the same day O’Day was post­ing his open let­ter, of­fi­cials at the EMA were urg­ing Gilead to fair­ly dis­trib­ute the drug in the EU.

Clin­i­cal tri­als re­main the gold stan­dard for the col­lec­tion of ro­bust da­ta on the safe­ty and ef­fec­tive­ness of in­ves­ti­ga­tion­al med­i­c­i­nal prod­ucts, but the CHMP ac­knowl­edges the need for a har­monised ap­proach to com­pas­sion­ate use in the EU to al­low ac­cess to remde­sivir for pa­tients who are not el­i­gi­ble for in­clu­sion in clin­i­cal tri­als”, said Har­ald Enz­mann, the chair of the CHMP. “The CHMP en­cour­ages the com­pa­ny to make remde­sivir avail­able in a fair and trans­par­ent way to those Mem­ber States wish­ing to take part in in­ter­na­tion­al clin­i­cal tri­als or treat pa­tients in com­pas­sion­ate use pro­grammes.”

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Covid-19 roundup: Buoyed by soar­ing shares, No­vavax inks a $167M deal to buy Covid-19 vac­cine-mak­ing fa­cil­i­ty; France cools on hy­drox­y­chloro­quine

The pandemic has offered the best news Novavax has had in years. Its stock price is trading at 7x the pre-panic levels with a Covid-19 vaccine in the mix, as investors buy anything that moves in that field, and they’re flush to carve out their own pathway on the manufacturing front.

Wednesday morning Novavax reported that they are spending $167 million on the Czech-based Praha Vaccines, bagging a manufacturing facility along the way.

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